Development of a delirium detection tool in hospice patients
| ISRCTN | ISRCTN97417474 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97417474 |
| IRAS number | 262658 |
| Secondary identifying numbers | AC19073, IRAS 262658 |
- Submission date
- 03/02/2020
- Registration date
- 21/02/2020
- Last edited
- 18/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Delirium is one of the most common and serious neuropsychiatric conditions affecting specialist palliative care (hospice) inpatients. Delirium is associated with increased morbidity and mortality. Patients' ability to communicate may be impaired, as may their decision-making ability and quality of life. If delirium is detected earlier or more accurately, it can result in better treatment for patients. However, delirium often goes unrecognised because of the lack of quick and simple ways to detect it. The ‘4AT’ is a short and simple bedside test for detecting delirium. Previous research studies have shown it to be an effective test in hospitalised patients. The 4AT is already used in hospices, however, it has not been proven in this setting. The aim of this study is to explore how accurately the 4AT can diagnose delirium in hospice inpatients.
Who can participate?
Patients aged 18 and over who are admitted to hospice inpatient units
What does the study involve?
Two sets of tests of thinking, memory and concentration will be done by the participant’s bedside by two different healthcare professionals (a nurse or a doctor). One set of tests will last around 2 minutes (the 4AT), and the other set (the reference standard delirium assessment) lasts up to 15-20 minutes. There are no treatments or invasive investigations. The researcher will also seek the participant’s permission to examine their medical notes, and speak to the hospice team looking after them and/or someone who knows them well.
What are the possible benefits and risks of participating?
The hospice team looking after the patient will be informed of the results of the assessments. It may help the patient’s care if they have this information. It is hoped that the results of the study will help nurses and doctors decide if they should use the 4AT test in hospice settings. The only disadvantage of taking part in the study is that the participant might find the questions irritating – however, the participant can choose to stop at any point if they wish. There are no significant risks in this study.
Where is the study run from?
The study is being held at Marie Curie Hospices in Edinburgh and Glasgow (UK)
When is the study starting and how long is it expected to run for?
January 2019 to March 2022
Who is funding the study?
Marie Curie (UK)
Who is the main contact?
Dr Elizabeth Arnold
liz.arnold@mariecurie.org.uk
Contact information
Scientific
Marie Curie Hospice
45 Frogston Road West
Edinburgh
EH10 7DR
United Kingdom
| Phone | +44 (0)131 470 2201 |
|---|---|
| liz.arnold@mariecurie.org.uk |
Study information
| Study design | Multicentre randomized cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN97417474_RecoveredCapacity_PIS_V4_14Aug19.pdf |
| Scientific title | Preliminary validation study of the 4AT delirium assessment tool in specialist palliative care inpatients |
| Study objectives | To determine the validity or accuracy of the 4AT for delirium detection versus a reference standard delirium assessment in specialist palliative care inpatient (hospice) populations. |
| Ethics approval(s) | Approved 15/10/2019, Scotland A Research Ethics Committee (Scotland A REC) (2nd Floor Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44 (0)131 465 5680; Manx.neill@nhslothian.scot.nhs.uk), ref: 19/SS/0091 |
| Health condition(s) or problem(s) studied | Delirium |
| Intervention | Participants will undergo two assessments for detecting delirium: 1. The 4AT, a quick, easy to use test, which takes around 2 min to complete 2. A reference standard delirium assessment, which takes up to 15-20 min to complete. The reference standard delirium assessment will be based on the core diagnostic criteria for delirium as documented in the fifth edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders. The two assessments will be completed independently by two clinicians. The order of the tests will be a randomised in a 1:1 ratio. The randomisation process will occur immediately after consent is obtained. During the assessment period, there will be no direct communication about the participant between the two clinicians, until both assessments are completed (other than to schedule the order of the tests). This is to ensure blinding of the assessment results. Given the fluctuating nature of delirium, the assessments will be completed within a maximum time period of 3 h, with a target time interval of 15 min. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. The accuracy of the 4AT in detecting delirium amongst hospice inpatients compared to the reference standard assessment centred on the DSM-5 criteria for delirium 2. The diagnostic accuracy of the 4AT assessed using specificity, sensitivity, positive and negative predictive values Measured at a single study visit |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2019 |
| Completion date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200-240 participants: the researchers are aiming to recruit 240 participants, across the 3 sites, allowing for two hundred participants with complete data suitable for analysis. |
| Key inclusion criteria | 1. Aged 18 years or over 2. Acutely admitted to a specialist palliative care inpatient unit |
| Key exclusion criteria | 1. Acute life-threatening illness requiring time-critical intervention 2. Coma 3. Unable to communicate in English. (The cognitive tests used have not been validated in non-English speakers, hence the study only includes patients who can communicate fluently in English.) 4. Severe dysphasia 5. Combined severe hearing and visual impairment, which would limit participation in the study’s tests 6. High level of patient and family distress, as judged by the clinical team |
| Date of first enrolment | 17/10/2019 |
| Date of final enrolment | 31/03/2022 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centres
Edinburgh
EH10 7DR
United Kingdom
Glasgow
G21 3US
United Kingdom
Sponsor information
University/education
ACCORD
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 242 3326 |
|---|---|
| resgov@accord.scot | |
| Website | http://www.accord.scot |
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 20/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The researchers plan to submit the protocol for publication and plan to publish information from the study in a peer-reviewed medical journal and/or present at a conference. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in the publically available repository at Edinburgh Datashare; https://datashare.ed.ac.uk/handle/10283/8794. The SPIRIT checklist has been uploaded as an additional file. (added 11/03/2021) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V4 | 14/08/2019 | 09/03/2021 | No | Yes |
| Participant information sheet | version V4 | 14/08/2019 | 09/03/2021 | No | Yes |
| Participant information sheet | version V4 | 14/08/2019 | 09/03/2021 | No | Yes |
| Other files | Spirit Checklist | 11/03/2021 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 26/04/2021 | 06/03/2024 | Yes | No | |
| Dataset | 07/06/2024 | 18/06/2024 | No | No | |
| Results article | 01/05/2024 | 18/06/2024 | Yes | No |
Additional files
- ISRCTN97417474_RecoveredCapacity_PIS_V4_14Aug19.pdf
- Uploaded 09/03/2021
- ISRCTN97417474_AdultsWithIncapacity_PIS_V4_14Aug19.pdf
- Uploaded 09/03/2021
- ISRCTN97417474_PIS_V4_14Aug19.pdf
- Uploaded 09/03/2021
- ISRCTN97417474 Spirit Checklist.pdf
- uploaded 11/03/2021
Editorial Notes
18/06/2024: The following changes were made:
1. Publication reference and total final enrolment added.
2. Dataset added.
3. IPD sharing plan and summary were added.
4. The intention to publish date was changed from 01/12/2020 to 20/05/2024.
06/03/2024: Publication reference added.
27/01/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/07/2020 to 31/03/2022.
2. The overall trial end date was changed from 31/08/2020 to 31/03/2022.
11/03/2021: St. Columba's Hospice was removed as a trial participating centre.
11/03/2021: The SPIRIT checklist was uploaded as an additional file.
09/03/2021: The participant information sheets have been uploaded.
24/04/2020: Due to current public health guidance, recruitment for this study has been paused.
13/02/2020: Trial's existence confirmed by Scotland A Research Ethics Committee.
